LABORATORY AND CLINICAL STUDIES OF IMIPENEM/CILASTATIN SODIUM IN THE PEDIATRIC FIELD

Abstract

Laboratory and clinical studies on imipenem/cilastatin sodium were carried out and the obtained results were summarized below.
The antibacterial activity of imipenem against clinical isolates of S. aureus, E. coli, K. pneumoniae, Salmonella sp., S. marcescens and P. aeruginosa was measured by the plate dilution method with an inoculum size of 10⁶ cells/ml.
The growth of S. aureus was inhibited at an imipenem concentration of 0.025 μg/ml or lower.
The susceptibility distribution of E. colt to imipenem ranged from 0.1 to 1.56 μg/ml, and the peak of the distribution was at 0.1μg/ml.
The peak of the susceptibility distribution of
K. pneumoniae
was 0.2 μg/ml, and those of
S. marcescens
and Salmonella ranged from 0.2 to 1.56 μg/ml and from 0.1 to 0.39 μg/ml, respectively.
The growth of P. aeruginosa was inhibited at a concentration of imipenem at 6.25 μg/ml.
For a pharmacokinetic study, imipenem/cilastatin sodium was given to 1 patient in a single dose of 10mg/kg or 20mg/kg by drip infusion over 1 hour. With drip infusion of imipenem/cilastatin sodium, the peak plasma levels obtained with the two doses (10 and 20mg/kg) were 20.6/26.4 μg/ml and 19.4/36.5 μg/ml, respectively on completion of the infusion.
Clinical responses to imipenem/cilastatin sodium were excellent in 6 patients and fairly good in 1 patient, and the clinical effectiveness ratio was 85.7%.
No side effect was observed except for elevations of GOT and GPT in 1 patient.